Ozempic Receives New Indications in Chronic Kidney Disease

The US Food and Drug Administration (FDA) approved semaglutide (Ozempic, Novo Nordisk) for reducing the risk for worsening kidney disease and cardiovascular death in adults with both type 2 diabetes and chronic kidney disease. 

The approval is based on the phase 3b results of the international FLOW kidney outcomes trial, which involved more than 3500 individuals with chronic kidney disease and type 2 diabetes, randomized to once-weekly semaglutide or placebo plus standard care. 

The trial achieved its primary endpoint with semaglutide 1 mg, producing a significant 24% relative risk reduction of kidney disease worsening, end-stage kidney disease, and death due to cardiovascular disease. The absolute risk reduction compared with placebo was 4.9% at 3 years.

This approval adds to Ozempic’s existing indications for adults with type 2 diabetes to improve glycemic control and to reduce the risk for major cardiovascular events in adults who also have known heart disease. 

“Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes,” said FLOW trial co-chair Richard E. Pratley, MD, medical director at the AdventHealth Diabetes Institute, Orlando, Florida, in a Novo Nordisk statement. 

Pratley added, “A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis. Today’s decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients.”

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape Medical News, with other work appearing in The Washington Post, NPR’s Shots blog, and Diatribe. She is on X: @MiriamETucker